FDA requires post-marketing tests of certain drugs for asthma

04/17/2011 | Reuters

The FDA is requiring drugmakers to conduct post-marketing studies to evaluate the safety of long-acting beta-agonists when combined with inhaled corticosteroids for patients with asthma. The tests are expected to begin this year. Four trials will enroll 46,800 patients age 12 and older. The agency also asked GlaxoSmithKline to separately evaluate its Advair Diskus in 6,200 children ages 4 to 11.

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